Skinny Label Lives – Section viii Carve-Out and Non-Infringement of Method of Treatment Patents
Back in August, the Federal Circuit’s GSK v. Teva opinion landed with quite a splash in the Hatch-Waxman world. In that case, Teva’s carvedilol “skinny label” (i.e. drug label with Section viii carve-out) did not serve to fend off a finding of induced infringement of a patent that claims the method of treatment that was […]
Upadhye Tang LLP – In Case You Missed It
Upadhye Tang LLP was founded a few years ago to focus on our core competencies: IP and FDA law. We know the life sciences business and clients trust us for our advice. And given the fierce competition, we are tough fighters for our clients. Let’s recap who we are and what we are about. We […]
The Role of Prosecution History (File Wrapper) in Patent Law
In patent litigation, most attorneys focus on the patent document itself. After all, the patent is being asserted in the litigation so it makes sense. But the patent document is not born in its final form. Rather, it starts as a patent application filed at the USPTO. The Examiner and applicant engage in the typical […]
Attorney Fee Awards in Patent Litigation
A lawsuit that goes to the bitter end will result in a winner and a loser. And with the win in hand, the winner then thinks it’s entitled to fees and costs as reimbursement. The typical situation in American court litigation is that everyone pays his or her own legal fees. This default standard is […]
A Lack of Essential Testing Method Parameter in Patent Claims Led to Indefiniteness, but Inequitable Conduct Is Hard to Prove – Lessons from Sun v. Lupin
In a recent District of New Jersey decision, Chief Judge Wolfson found a patent indefinite, obvious, and not infringed (due to a failure of proof). Sun Pharma v. Lupin, 2021 WL 4473411 (Sept. 30, 2021). However, the court did not find inequitable conduct by clear and convincing evidence, despite the inventor’s “hubris” and incorrect understanding […]
Inequitable Conduct Defense During Patent Litigation
in a 505(b)(2) NDA Context
The § 505(b)(2) regulatory pathway gives a smaller pharmaceutical company, a start-up company even, the opportunity to submit and obtain FDA approval of a new drug application (NDA) without breaking the bank. A 505(b)(2) NDA may rely heavily on data from an already-marketed drug product and information in published literature to demonstrate the safety and […]
IPR Estoppel – A Truly Double-Edged Sword
Since its creation by the America Invents Act of 2011, Inter Partes Review (or IPR) has been a valuable tool for current or future patent defendants. However, the risk/reward calculus has changed over the years since the IPR originated. In particular, the estoppel effects of an IPR decision are now a much more important consideration […]
Tools to Combat Frivolous Hatch-Waxman Cases
Generic pharmaceutical companies and §505(b)(2) NDA filers routinely use Paragraph IV certifications to challenge the patents a brand company listed on the FDA’s Orange Book. Such a challenge generates subject matter jurisdiction for patent infringement suits. When the brand company timely sues, FDA approval of the patent challengers’ applications is automatically stayed for 30 months […]
Opinions of Counsel & Freedom to Operate: Are They Relevant Again?
An Opinion of Counsel or Freedom To Operate (FTO) opinion though not legally required often, is a good business practice. First, a company may seek the FTO opinion for due diligence, merger & acquisition, and for other deal-making needs. For many companies, a question exists: “If we launch this product into the marketplace, will we […]
2021 Post-COVID Trends in Patent Litigation
Though we don’t know when, someday life will return to normal. And we may redefine what the new normal is. But we do know that patent litigation will persist. Therefore, we can examine some post-COVID trends. In-Person Court Hearings and Trials Over the last year, we got used to conducting all hearings and even trials […]
